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Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Uterine Cervical Neoplasms

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Trial Information

Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients


Patients with cervical cancer receiving post-operative radiotherapy (RT) for high risk
features found on pathologic review will be treated with pelvic intensity modulated
radiation therapy (IMRT). Helical tomotherapy will be used to plan and deliver the
radiation treatment. Treatment volume will include the upper third of the vagina and
para-vaginal tissue and the common, external and internal iliac nodal regions. External
beam radiation will be delivered in 180 cGy daily fractions to a total dose of 5040 cGy.
Patients will receive once a day treatment five days a week, for approximately 6 weeks.
Concurrent chemotherapy and/or intracavitary brachytherapy may be included in the treatment
plan at the discretion of the treating physician, consistent with routine clinical practice.


Inclusion Criteria:



- Age >= 18

- Karnofsky Performance Status of >= 60

- FIGO Stage I -IIB

- Pathologic confirmation of cervical cancer

- Status post hysterectomy

- Patients with local or regional metastases are eligible for this protocol, but not
those with distant metastases

Exclusion Criteria:

- Age < 18

- Karnofsky Performance Status < 60

- Radiographic or pathologic evidence of distant metastatic disease

- Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy
irradiation for acute hemostasis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the feasibility of using helical tomotherapy to deliver IMRT

Outcome Description:

Feasibility is defined as the ability to deliver 95% of the prescription dose to 90% of the original planning target volume in at least 90% of the patients, as verified by actual dose delivered calculations using on board CT scan.

Outcome Time Frame:

After all patients are enrolled and complete treatment

Safety Issue:

No

Principal Investigator

Perry W Grigsby, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University Medical School

Authority:

United States: Institutional Review Board

Study ID:

05-0977 / 201104019

NCT ID:

NCT00359866

Start Date:

February 2006

Completion Date:

July 2015

Related Keywords:

  • Uterine Cervical Neoplasms
  • Neoplasms
  • Uterine Cervical Neoplasms

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110